As 2018 begins, the dietary supplement industry
in the United States reflects on self-regulatory initiatives that go back 30
years and precede the passage of the signature legislation dealing with
supplements, the Dietary Supplement Health and Education Act of 1994 (DSHEA).
In June of 2017 several industry
stakeholders, including the trade associations the American Herbal Products
Association (AHPA) and the Council for Responsible Nutrition (CRN), went to
Capitol Hill to meet with members of Congress about past accomplishments and
ongoing efforts, even though the Trump Administration seems to be backing away
from strong regulatory efforts.1 Such visits are a never-ending
requirement for an industry often suffering from a mistaken view of its efforts
and a long-held misconception that it is unregulated.2
Michael McGuffin, president of AHPA, knows
this as well as anyone. Although he acknowledges the many other industry groups
that are committed to long-term self-regulatory efforts, such as CRN, the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA), he
stated that AHPA, founded in 1982, has been a central player in relation to
self-regulation and has long forged a trail in these programs (oral
communication, December 5, 2017).
McGuffin said that the efforts were not
from some prescient knowledge of issues to come, but rather because doing so
was consistent with AHPA’s mission, which is “to promote the responsible
commerce of herbal products to ensure that consumers continue to enjoy informed
access to a wide variety of herbal goods.”3
Supporting
Responsible Commerce
“I think it is fair to say we were a trail
blazer in these types of efforts and [it is] accurate that we established
standards of practice early in our existence to respond to circumstances as we
became aware of them,” McGuffin said. “We have always felt that this was part
of our identity and service to the trade, which extends beyond our members. But
I will tell you, it is directly associated with our mission to support responsible
commerce. We weren’t just trying to support ‘commerce,’ but ‘responsible commerce.’
By adding the word ‘responsible,’ it
made our jobs a lot harder.”
Loren
Israelsen, president of UNPA, was an early officer of AHPA and remembers the pioneering
days when AHPA was “working to build a new voice for the still-adolescent herb
industry” (email, December 11, 2017).
“For
reasons beyond me, I was elected a founding officer of AHPA in 1982,” said
Israelsen. “AHPA was my ‘hood,’ and many of my oldest and most cherished
relationships came out of those early days. While AHPA board meetings are now highly organized and committees
tackle the toughest issues of the day, at the heart of AHPA remains a deep
commitment to advancing the safe and beneficial use of herbs.”
McGuffin noted that AHPA programs have
always evolved and reflected a balance between the reactive and the proactive. Maybe,
he said, AHPA might have adopted certain programs earlier, if, for example, it
could have foreseen the need for Herbs of
Commerce or restrictions on caffeine-containing products earlier. “But that
is not how the world works,” he said. “What we are expected to do is respond to
situations as they arise. We do try to predict or adopt some initiatives before
there is a problem to be fixed. That is the nature of things as we move through
our business lives. There are always new issues to deal with” (oral
communication, November 28, 2017).
That being said, AHPA didn’t see a clear or
significant problem when they set out to publish the Botanical Safety Handbook, the 1997 publication intended to
evaluate herb safety and assure safe access to a wide range of herbs and herbal
products, which is arguably one of the group’s signature achievements. However, there was a realization within the
organization that it would be best to address the issues of botanical safety
internally rather than leave the issue to other groups without the knowledge
and expertise in herbs or with a position contrary to supporting consumer use
of herbs.
McGuffin largely attributed the genesis of
this philosophy to one member: Daniel Gagnon, a Santa Fe, New Mexico-based
herbalist and owner of retail store and extract manufacturer Herbs, Etc., who
was standing for election to the AHPA board during the mid-1990s when the
association was working on the Botanical
Safety Handbook. “Daniel said that AHPA needed to control the message on
botanical safety rather than let our detractors control that message,” he said.
The book, which was years in the making,
started with this concept, and McGuffin, Gagnon, and other members investigated
potential models from other organizations that had done self-regulatory work. They found one such model from the Flavor and Extract Manufacturers Association
(FEMA), which had developed an industry-sponsored generally recognized as safe
(GRAS) assessment program after the US Food and Drug Administration (FDA) took
action to reclassify flavors as food additives (substances requiring premarket
safety approval by FDA before they can be added to food products). It has become
an extensive program with a sound record of scientific rigor and transparency.5,6
McGuffin, Gagnon, and other AHPA
representatives went to John Hallagan, general counsel for FEMA, to discuss the
program. “He was very supportive and encouraged us to take on the task,”
McGuffin said. He recalled that Hallagan was very stern and advised them to be
thorough and not look for short cuts. “He told us ‘you can’t exonerate everything.’”
“The point is,” McGuffin added, “people at
the time were not talking about unsafe herbs. There weren’t gross numbers [of
consumers] being harmed by chamomile [Matricaria
recutita, Asteraceae] and echinacea [Echinacea
spp., Asteraceae]. But one in our community said, ‘we need to take
responsibility for this. It is not a clear and present danger, and we are not
being damaged by a regulator. We must do this because it is the right thing to
do and we have the expertise.’”
Lessons
Learned
It was a premise that has since served AHPA well, and the association continuously
strives to adapt and bring as many players to the table as possible to develop
the programs. It was a lesson, McGuffin said, that he learned early. AHPA’s
first initiative, established in 1988 to prohibit the international and
domestic trade of wild-crafted lady slipper (Cypripedium spp.,
Orchidaceae), is a good example of this thinking. At the time, the entire
orchid family was listed in Appendix II of the Convention on International
Trade in Endangered Species of Wild Fauna and Flora (CITES), a designation which
lists species that are not currently threatened with extinction but may become
so unless trade is closely controlled.4
AHPA leaders knew that lady slipper had the
attention of the international treaty, but that it wouldn’t have an impact on
domestic trade, which made up a majority of the market.
AHPA quickly learned that these type of programs
would not be an easy sell. In establishing the lady slipper policy, for
example, McGuffin said they considered the impact of the ban to members and
community beforehand, and recognized that there were adequate herbal sedative substitutes
for lady slipper that could offer beneficial value and provide quality in
products. “We felt that the impact would be minimal,” he said; however, initial
reaction to the initiative was mixed. “We did hear from some companies that
were marketers of wild material and herbal ingredient suppliers who thought
that our action was unnecessary, and that the plant was not at risk due to
harvest pressure,” he said. “But mostly, what I remember was that members said
they would have liked to have been more a part of the discussion.”
The early feedback was that such programs
were not completely wrong, he said, but the stronger message was that the
decision-making process was not inclusive of the broader community. To address these concern AHPA now engages a
broad cross-section when it initiates a new self-regulatory recommendation.
Bringing stakeholders to the table is an
ongoing process that continues to develop. In 2017, McGuffin said, AHPA adopted
a policy for supplements containing fungal ingredients and had to deal with
widely divergent points of view regarding the value of the fruiting body and
the mycelium and how products should be labeled. “We kept bringing both sides
together to create a respectful forum to talk. There were still disagreements,
but we pushed each side for what they could give,” he said. It is a difficult
process, he added, but “one way to know you have a good compromise is that
neither party likes it much. Is everybody happy? Maybe not, but we are seeing
compliance.”
Throughout the 1990s, AHPA established a
number of initiatives, such as label guidelines and usage cautions for herbs
and products, including chaparral (Larrea
tridentata, Zygophyllaceae), stimulant laxatives, pyrrolizidine alkaloids,
and kava (Piper methysticum,
Piperaceae), as well as policies regarding claims that a supplement can mask the presence
of illegal drugs in the body, and added constituents.2 One of the
key self-regulatory highlights of the decade was the 1992 publication of the
first edition of Herbs of Commerce,
which was a self-governing guidance that established a single standardized common
name for each of the herbs listed, with a goal to help prevent potential
confusion and misuse of botanicals by manufacturers and consumers.
“We realized that the same ingredients were
being sold in the market under different names and to a degree the consumer
couldn’t tell what they were buying,” McGuffin explained. For example, eleuthero
(Eleutherococcus senticosus,
Araliaceae) was being sold under various names such as “Siberian ginseng,” and
kola nut (Cola spp., Malvaceae) was
being sold as “bissy nut.” There was concern that the name was being used
instead of kola nut to move consumers away from the idea that the product
contained caffeine, McGuffin explained. AHPA took on the task of becoming the
authority for standardizing these common names, contracting with author and botanical
expert Steven Foster to produce the document.
The publication eventually became incorporated
in 1997 into the Food and Drug Administration’s (FDA) rules for labeling dietary supplements as
directed in DSHEA.7 The regulation was codified at 21 CFR 101.4 (h)
and states that “The common or usual name of the ingredients of dietary supplements
that are botanicals (including fungi and algae) shall be consistent with the
names standardized in Herbs of Commerce,
1992 edition, which is incorporated by reference in accordance with 5 U.S.C.
(a) and 1 CFR part 51.”8
AHPA published a second edition of Herbs of Commerce in 2000, which
included nearly 1,500 additional species compared to the first edition (2,048
separate species as opposed to 550). The second edition allowed many
ingredients that had been used in products to be identified from then on by
their common names rather than their Latin binomials.7
“The incorporation of Herbs of Commerce was a great acknowledgement of the value of our
work,” McGuffin said, “and, more importantly, it was a stepping stone to help
move industry self-regulatory efforts into formal regulatory references.”
From
Self-Regulation to Law
This was not the only time that an AHPA
program served as a credible and authoritative option for regulators. AHPA’s
position on adverse event reporting in 2002 moved from an industry self-regulatory
effort all the way to law, and is an example of how these policies can progress.
It began when the AHPA board took the position that the FDA should establish a
requirement for marketers of dietary supplements to communicate reports of
serious adverse events caused by their products to the FDA.9 The
process took several years, with AHPA filing a Citizen Petition in 2003 asking the
FDA to create regulations that would mandate adverse event reporting and noting
that the agency had in numerous instances exercised its rule-making authority to
put in place requirements that would advance its public health objectives.9
The FDA originally said it did not have the
authority to do this, McGuffin recalled, but AHPA believed that it was wrong
and partnered with other groups, such as the Consumer Healthcare Products
Association (CHPA), to convince them otherwise. Beyond CHPA, AHPA also garnered
support from numerous industry watchers with a wide spectrum of views about
supplement regulation. “We got bipartisan support from industry leaders in
Congress, including some of our staunchest allies, such as Sen. Orrin Hatch [R-UT]
and our most committed detractors, like Sen. Dick Durbin [D-IL], as well as support
from consumer groups like CSPI [the Center for Science in the Public Interest]
and Consumers Union. It was a remarkable exercise, but everyone recognized the
need,” he said.
The proposal was eventually adopted as part
of the Dietary Supplement and Nonprescription Drug Consumer Protection Act,
which was signed into law in December 2006, with compliance required a year
later.10 “There was initially some support and some resistance to
this, but we felt we had a responsibility to support responsible commerce and
that included informing regulators when something goes wrong. In this instance,
we took something that started as a self-regulatory initiative to engage our
members and support the community and then moved to make it a formal, public
initiative,” McGuffin said.
Another signature program is the Botanical
Authentication Program that was established in 1997, originally as AHPA’s Guidance on Known Adulterants.11
At the time, McGuffin said, AHPA recognized that there were potential mix-ups
or intentional substitutions of certain herbs, so the program set out to
identify herbs and potential adulterants that were known to be in trade. “We
didn’t evaluate whether it was an intentional adulteration or simply an
accident. In each case, there was a known substitute that had the potential to
cause significant [adverse] health effects, so we were focused on safety
issues.” The program started with a list of four ingredients, including aristolochic
acids (a family of phytochemicals commonly found in the family Aristolochiaceae),
stephania root (Stephania tetrandra,
Menispermaceae), skullcap herb (Scutelleria
lateriflora, Lamiaceae) and eleuthero root, which were identified as potentially
adulterated and provided a guidance to help manufacturers dealing with those ingredients,
so they could double- and triple-check that they had the right ingredient.
The ongoing and dynamic program has evolved
over the past 20 years as part of AHPA’s Botanical Authentication Program with
additional ingredients, such as black cohosh (Actaea racemosa, Ranunculaceae) as well as grapefruit (Citrus paradisi, Rutaceae) seed extract
added to the list. The program also provides members and industry with online
tools to ensure ingredient identity and quality.
AHPA also has led the way with guidance
documents that provide specific and detailed information about herbal
ingredients. “AHPA’s 2000 Guidance Policy on extract retail labeling continues
to be instructive to companies that want to increase their supply chain knowledge
and transparency,” said Steven Dentali, PhD, a former AHPA chief science
officer. “Knowing the precise nature of the extracts manufacturers purchase
from suppliers is made easier when the basic botanical principles are
understood. AHPA continues to be at the forefront of trade associations focused
on developing herbal standards and communicating them to the wider stakeholder
community,” he added.
Table 1. Selected AHPA Self-Regulatory Efforts
|
Program/Publication Name
|
Year Established/Updated
|
Herbs of Commerce
|
1992
(1st ed.), 2000 (2nd ed.)
|
Botanical Safety Handbook
|
1997
(1st ed.), 2013 (2nd ed.)
|
Botanical
Authentication Program
|
1997
|
New Dietary Ingredient (NDI) Database
|
2005
|
Good
Agricultural and Collection Practices and Good Manufacturing Practices for
Botanical Material (white paper)
|
2006,
2017
|
Botanical Identity References Compendium
|
2014
|
Good Herbal Compounding and Dispensing Practices
(white paper)
|
2017
|
What Has
the Industry Learned?
Despite AHPA’s extensive list of self-regulatory
accomplishments, the investigation by New York Attorney General Eric
Schneiderman that began in early 2015 once again indicated that the botanical
and supplement industries still faced many powerful detractors and significant
misconceptions about regulatory status. While the allegations against numerous
leading manufacturers and retailers prompted an unprecedented industry effort
to work together toward self-regulation, it still rankles McGuffin for a number
of reasons. “The primary issue that I challenge is the idea that world history
went like this: Step one: we are bad. Step two: Eric Schneiderman said ‘you are
bad.’ Step 3: we decided to be good. That is a false narrative. The true story
is, we were good to begin with. We were always involved with these issues. We
didn’t start self-regulating in 2015.”
Correcting the record is a common theme
when McGuffin speaks. In his keynote address of the 2016 Rocky Mountain Dietary
Supplement Forum, he rejected the idea that the 2015 investigation by the NY AG
was the sole event that prompted the industry to behave honorably. “These new
initiatives do not represent the industry’s first foray into self-regulation,
and I reject any suggestion that we have arrived at the point of creating new
programs under duress.”12
He does acknowledge that the investigation
has provided a stepping-off point for more declaration of self-regulatory initiatives.
One such effort, he said, is the re-emergence of AHPA’s Good Agricultural and
Collection Practices (GACPs), first established in 2006 in partnership with Roy
Upton and the American Herbal Pharmacopoeia. The initiative was modeled after
various other programs around the world. Some ideas were original, and some were
borrowed with a focus on the US market, McGuffin explained. “We produced it. We
posted it, but we didn’t keep our attention on it.”
That is, until consultants for GNC, facing
legal issues from Schneiderman, copied the document from the AHPA website and
then crafted a revised version with a more contemporary focus and input from
herbal suppliers and manufacturers to establish appropriate controls all the
way back to seed and harvest, McGuffin said. GNC then gave the document back to
AHPA to put in additional context from a trade association perspective. The
document, which now includes Good Manufacturing Practices for Botanical
Material, as well as GACPs, was formally approved in March 2017 and has since
been endorsed by a variety of other industry associations, such as CHPA, CRN,
and UNPA. The free assessment tools are designed to help the herbal products
industry evaluate and document policies and procedures that ensure high-quality
herbs and herbal ingredients throughout the supply chain.2
In a letter of endorsement for the guidance,
Israelsen wrote: “UNPA is confident that this comprehensive guidance and its
accompanying assessment tools will help promote proper identification of and
reduce the adulteration of botanical raw materials, with a goal of providing
high-quality ingredients for dietary supplements and other natural health
products. We will encourage our member companies to incorporate the AHPA
GACP-GMP into their own growing, procurement and processing operations.”13
A New
Era
Though the challenges will likely continue,
McGuffin remains optimistic for the future and believes there is still strong
momentum going forward. “I think there is still a lot of interest in countering
the image of the dietary supplements industry as unregulated,” he added. “We
know it’s false, but we also recognize now that we are not going to change that
by just saying ‘nu-uh.’ The only way to change that is with respect for the foundational
companies that are making the best-quality products, and then indicating to
consumers in a public manner that they are going a step beyond what is
required.”
In the end, McGuffin added, it comes down
to the consumer who will continue to demand access to herbal products and, as
they become more knowledgeable and information is more accessible, they will
buy from companies that meet appropriate quality standards and share their values.
Industry in turn will have no choice but to continue with self-regulatory
initiatives that meet this demand. “One thing is not leading the other,” he
said. “There is a valuable and productive tension between consumers and
industry and the next generation will keep the process going and industry self-regulation
will be a part of the program then, just as it is today.”
—Karen Raterman
Image credits (top to bottom): AHPA logo AHPA’s Botanical Safety Handbook Pink lady’s slipper orchid (Cypripedium acaule) ©2018 Steven Foster.
References
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JB, Hall R. Under the conditions of intended us — New Developments in the FEMA
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- Herbs of Commerce becomes law of the
land for labeling. [press release]. Silver Spring, MD; American Herbal Products
Association. November 7, 2005. Available at: www.newhope.com/supply-news-amp-analysis/herbs-commerce-2nd-edition-becomes-law-land-labeling.
Accessed December 8, 2017.
- US Food
and Drug Administration. 21 CFR §101.4. Food for human consumption: food
labeling. In: Code of Federal Regulations.
Washington, DC: US Government Printing Office; 2017. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.4.
Accessed February 1, 2018.
- American
Herbal Products Association Supports Serious Adverse Event Reporting for
Dietary Supplements [press release]. Silver Spring, MD. American Herbal
Products Association. June 6, 2004. Available at: www.newhope.com/supply-news-amp-analysis/american-herbal-products-association-supports-serious-adverse-event-reporti.
Accessed on December 8, 2017.
- Adverse
Event Reporting: Considerations and Med Watch Worksheet for Receiving AERs
Associated with Dietary Supplements. AHPA website. Available at: www.ahpa.org/Resources/TechnicalGuidance/AHPAGuidanceDocuments/TabId/401/ArtMID/1244/ArticleID/222/Adverse-Event-Reporting-Considerations-MedWatch-Worksheet-for-Receiving-AERs-Associated-with-Dietary-Supplements.aspx.
Accessed Dec. 8, 2017.
- AHPA
Botanical Authentication Program. AHPA website. Available at: www.ahpa.org/Resources/TechnicalGuidance/ScientificAffairs/BotanicalAuthenticationProgram.aspx.
Accessed December 8, 2017.
- AHPA
Launches GACP-GMP Assessment Program. AHPA Website. Latest news. Available at www.ahpa.org/News/LatestNews/TabId/96/ArtMID/1179/ArticleID/847/AHPA-Launches-GACP-GMP-Assessment-Program.aspx.
Accessed December, 8, 2017.
- UNPA
Endorses AHPA’s Good Agricultural and Collection Practices and Good
Manufacturing Practices for Botanical Material [press release]. Salt Lake City.
November 28, 2017. Available at: www.ahpa.org/News/LatestNews/TabId/96/ArtMID/1179/ArticleID/890/UNPA-endorses-AHPAs-Good-Agricultural-and-Collection-Practices-and-Good-Manufacturing-Practices-for-Botanical-Material.aspx.
Accessed December 10, 2017.
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